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Not yet recruitingNCT07936058Updated Nov 13, 2026

A Phase I Study to Evaluate the Food Effect on Ecnoglutide Tablet

A Phase 1 interventional study of Dose 1 and Dose 2 in Food Effect in Healthy Volunteers and Weight Management, sponsored by Hangzhou Sciwind Biosciences Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Hangzhou Sciwind Biosciences Co., Ltd. · Phase 1, Interventional, and Treatment

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 10 studies in Obesity by Hangzhou Sciwind Biosciences Co., Ltd. — 7 open to participants now, 8 under way, 4 of them phase 3. Obesity · Hangzhou Sciwind Biosciences Co., Ltd..

Planned enrollment
9th of 10
72 · median 152
Started
2026
with 5 others
Phase 1
2 of 10
1 open now
Registered
10th of 10
by date

Among the 10 studies in Obesity by Hangzhou Sciwind Biosciences Co., Ltd., this one is the 9th largest by planned enrollment, is one of 6 that started in 2026, is one of 2 in phase 1, and was the 10th registered.

Obesity

11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.

Browse Obesity studies →

Open to participants now

7 of the 10 studies in Obesity by Hangzhou Sciwind Biosciences Co., Ltd. are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 1,339 Obesity studies recruiting now, 377 (28%) set no upper age limit and 859 (64%) stop at 75 or younger; 167 take children under 18; 490 take healthy volunteers.

This study: 18 Years to 50 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Obesity by Hangzhou Sciwind Biosciences Co., Ltd., or all of them as a file.
02

Study summary

The aim of the study is to evaluate food effect on pharmacokinetics of oral ecnoglutide tablets in Chinese participants

Read the detailed description

There are two parts in this study. Part I will assess the effect of high-fat meal, while eligible participants will be randomized and allocated to either cohort F1(fasting) or F2(with meal) in a ratio of 1:1 to receive oral ecnoglutide tablet for up to 14 days. Part II will assess the effect of different dosing conditions, while eligible participants will be randomized and allocated to either cohort T1(no intake after 30min of dosing) or T2(no intake after 60min of dosing) in a ratio of 1:1 to receive oral ecnoglutide tablet for up to 14 days.

03

Conditions studied

  • Food Effect in Healthy Volunteers
  • Weight Management

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Keywords

  • ecnoglutide
  • glucagon-like peptide-1 (GLP-1)
  • obesity
  • food effect
  • weight management
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. (BMI): 19.0 kg/m² ≤ BMI \< 30.0 kg/m², with body weight ≥ 55 kg (male) or ≥ 50 kg (female);
  2. Participants of agree to have no plans for pregnancy during the entire study period and within 6 months after the last dose: female participants must be non-pregnant and non-lactating, with no plans to donate ova, and male participants must have no plans to donate sperm; all participants voluntarily use effective , with female participants avoiding pregnancy and male participants avoiding causing pregnancy in their partners;

Exclusion criteria

Exclusion Criteria:

  1. History of severe drug allergy (especially known or suspected allergy to any component of Ecnoglutide Tablets, regardless of the severity of previous allergic reactions), or severe atopic allergic disease/history (e.g., asthma, urticaria, eczematous dermatitis, etc.), or discretion by the investigator to have a severe allergic condition (e.g., allergy to two or more drugs/foods, or repeated allergic reactions requiring medical intervention);
  2. Diagnosis of overweight or obesity of endocrine origin, such as Cushing's syndrome;
  3. Diagnosis of diabetes mellitus of any type (excluding gestational diabetes mellitus);
  4. History of acute or chronic pancreatitis, pancreatic injury, symptomatic biliary disease, or other high-risk factors that may lead to pancreatitis;
  5. Diagnosis of other endocrine diseases of significant clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging showing C-TIRADS ≥ 4A), thyroid cancer, or a personal or family history of multiple endocrine neoplasia type 2 (MEN2);
  6. Occurrence of severe gastrointestinal diseases, including but not limited to inflammatory bowel disease, active ulcers, severe irritable bowel syndrome, celiac disease, recurrent dyspepsia, or clinically abnormal gastric emptying (e.g., pyloric obstruction), within 6 months prior to screening; or presence of gastrointestinal symptoms such as nausea, vomiting, diarrhea, or constipation at screening/before the first dose;
  7. Occurrence of severe hypoglycemia or recurrent symptomatic hypoglycemia (≥ 2 episodes within 6 months) (e.g., anxiety, dizziness, sweating, tremor, hunger, and poor concentration, etc.), within 6 months prior to screening;
  8. Diagnosis of malignant tumor within 5 years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc., as discreted by the investigator to be clinically insignificant;
  9. History of depression, or other severe psychiatric illness, or suicidal ideation or suicidal behavior;
  10. Within 3 months prior to screening, participation in and use of any drug, vaccine, special medical food, or invasive device clinical trial, or planned participation in other clinical trials during the study period;
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    F1

    Day 1 to Day 14: Fast overnight for at least 10 hours before each dose, and take the tablet with 240 mL of plain water. No food intake is allowed within 4h after dose administration.

    Drug: Dose 1 · Drug: Dose 2

  • Experimental
    F2

    Day 1 to Day 13: take breakfast within 30min before each dose, and then take the tablet with 240 mL of plain water. No food intake is allowed within 4h after dose administration. Day 14: take breakfast with high fat and high calorie

    Drug: Dose 1 · Drug: Dose 2

  • Experimental
    T1

    Day 1 to Day 14: fast after 30min of dosing

    Drug: Dose 1 · Drug: Dose 2

  • Experimental
    T2

    Day 1 to Day 14: fast after 60min of dosing

    Drug: Dose 1 · Drug: Dose 2

Interventions

  • DrugDose 1

    oral, once daily for 7 days

  • DrugDose 2

    oral, once daily for 7 days

06

What researchers measure

Primary outcomes

  1. Maximum concentration

    Cmax of ecnoglutide

    Time frame: From Day1 to Day42

  2. Minimum concentration

    Cmin of ecnoglutide

    Time frame: From Day1 to Day42

  3. Area under the curve from time 0 to infinity

    AUC0-∞of ecnoglutide

    Time frame: From Day1 to Day42

  4. Area under the curve from time 0 to 24h

    AUC0-24h of ecnoglutide

    Time frame: From Day1 to Day42

  5. Area under the curve from time 0 to last quantifiable time point

    AUC0-t of ecnoglutide

    Time frame: From Day1 to Day42

  6. Time to reach maximum concentration

    Tmax of ecnoglutide

    Time frame: From Day1 to Day42

Secondary outcomes

  1. The incidence of adverse events

    Time frame: From Day1 to Day42

  2. Anti-drug antibody

    ADA of ecnoglutide

    Time frame: From Day1 to Day42

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.

Of 334 industry-sponsored phase 1 interventional studies under Obesity, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 5 months is below that.

Counting every sponsor, half of 439 studies reached it within 11 months; a quarter within 6 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2026
First posted
Nov 13, 2026
StartEst.
Nov 3, 2026
Primary completionEst.
Apr 15, 2027
CompletionEst.
Apr 15, 2027
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07936058
Lead sponsor
Hangzhou Sciwind Biosciences Co., Ltd.
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Nov 3, 2026 (estimated)
Primary completion
Apr 15, 2027 (estimated)
Completion
Apr 15, 2027 (estimated)
Last update
Nov 13, 2026

Study contacts

Yao Li
Contact
ra@sciwindbio.com
010-67889253
Yiwen Zhang
principal investigator · Zhejiang Provincial People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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